SUPPLY CHAIN ARTICLES
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Can America's Retreat On mRNA Be Europe's Opportunity?
With HHS winding down mRNA vaccine development under BARDA, could Europe seize the opportunity to lead in mRNA innovation? Exploring the policy shift's implications.
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mRNA Vaccines: Key Considerations For Development & Manufacturing
As we wind down National Immunization Awareness Month, this article looks at the complexities around developing and manufacturing mRNA vaccines and how you should address those complexities. Topics include delivery, process validation, long-term effectiveness, GMP, regulatory approval, and more.
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Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future Directions
Overall, I felt that the following initiatives/talking points were demonstrative of the types of creativity and symbiosis that we will need much more of in the near and long-term to foster a healthy and fruitful RNA ecosystem.
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“Holy T7 Polymerase, Batman!”: R&D Considerations For More Awe-Inspiring xRNA
It goes without saying we have some pretty ambitious therapeutic goals for linear mRNA and next-gen saRNA and circRNA. However, as my conversation with Koeris explored, we still have a lot of scientific and technical work/innovation ahead of us to make our RNA products “stronger” (in more ways than one).
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Inside Alnylam's Playbook For High Volume siRNA Production
As one of the first companies to establish a chemoenzymatic ligation platform, Alnylam's Maines and Nechev are in the perfect position to espouse wisdom on the practical aspects and remaining challenges of implementing enzymatic ligation at a large scale. Here in this installment, Maines and Nechev outline what they’ve learned thus far about the science of enzymatic ligation, while also paying credence to the unknowns and existing barriers that, as a frontrunner, Alnylam will inevitably (but willingly) be tasked with facing in the future.
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Picasso, Pick-Up Lines, & Personalized Medicine: mRNA's Path Forward
Overall, my presentation on what the mRNA industry can learn from the artist Picasso singled out a few specific areas from which I felt our industry could garner greater inspiration and operational prowess. But given how “collaborative” many of these sources of inspiration are, I’ve introduced each of my takeaways with a surprisingly relevant (albeit bad) art-themed pick-up line. After all, if there’s one sector that knows it takes more than one to “tango,” it’s the mRNA industry.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Uncover how how switching from LAL to rFC can enhance sustainability, improve testing reliability, and strengthen supply-chain resilience in endotoxin testing.
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Learn about the first end-to-end cGMP facility that was developed for mRNA manufacturing to address the shortage of CDMOs and the inadequate and inefficient supply chain options for sourcing GMP mRNA.
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GMP-Source, which is a term we coined, serves the purpose as a highly qualified raw material for a generation of virus, messenger RNA template, and transgenic expression of proteins.
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Explore the challenges impacting clinical supply chains and solutions to overcome these complexities, and understand why it is crucial to pick the right supply chain provider for vaccine storage and distribution.
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CRISPR technology is revolutionizing cell and gene therapies, but how do CRISPR clinical trials work? Follow this explanation of CRISPR therapies from the discovery phase to FDA approval.
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An alternative to traditional polyethylene bags is offering cell and gene therapy manufacturers a solution to contamination concerns regarding DNA or RNA fragments.
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Read through the results of our efforts to produce an optimal protocol for the transient transfection of hMSCs with pDNA or mRNA using non-viral means.